Fluorine F 18 Clofarabine PET/CT in Imaging Patients With Autoimmune or Inflammatory Diseases

Early Phase 1

Completed

• Conditions: Autoimmune Disease; Crohn Disease; Rheumatoid Arthritis; Inflammatory Disorder; Systemic Lupus Erythematosus; Takayasu Arteritis
• Interventions: Procedure: Computed Tomography; Radiation: Fluorine F 18 Clofarabine; Procedure: Positron Emission Tomography

• Registration Number: NCT02925351
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief Summary

This pilot trial studies how well fluorine F 18 clofarabine positron emission tomography (PET)/computed tomography (CT) works in imaging patients with autoimmune or inflammatory diseases. Fluorine F 18 clofarabine is an imaging agent or tracer which may be taken up by inflammatory tissue in the body. Diagnostic imaging, such as PET/CT scans, can be used to measure the amount of injected tracer that is taken up by inflammatory tissue. PET/CT scan may help to determine how fluorine F 18 clofarabine is distributed throughout the body.

Detailed Description

PRIMARY OBJECTIVES:

I. Determine how fluorine F 18 clofarabine (18F-clofarabine) is distributed in the body, in patients with autoimmune and inflammatory diseases.

II. Determine whether 18F-clofarabine can be used to image patients with autoimmune and inflammatory diseases.

OUTLINE:

Patients receive fluorine F 18 clofarabine intravenously (IV) and undergo a single PET/CT scan for up to 120 minutes.

Study Timeline

• Study Start: 2016-01-25
• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2016-10-04
• Study First Posted: 2016-10-05
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30
• Status Verified: 2019-11
• Last Update Submitted: 2020-09-02
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Must be 18 years or older.
• Diagnosed with an autoimmune and inflammatory disorder.

Exclusion Criteria

• Women of childbearing age will have to undergo a pregnancy test that will be provided free of charge.
• Patients unable to undergo or comply with PET/CT scanning due to pre-existing medical conditions including claustrophobia.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Imaging (fluorine F 18 clofarabine, PET/CT)	Positron Emission Tomography	Patients receive fluorine F 18 clofarabine IV and undergo a single PET/CT scan for up to 120 minutes.
Imaging (fluorine F 18 clofarabine, PET/CT)	Computed Tomography	Patients receive fluorine F 18 clofarabine IV and undergo a single PET/CT scan for up to 120 minutes.
Imaging (fluorine F 18 clofarabine, PET/CT)	Fluorine F 18 Clofarabine	Patients receive fluorine F 18 clofarabine IV and undergo a single PET/CT scan for up to 120 minutes.

Primary Outcome Measures

Name	Time	Method
Standardized Uptake Value	Baseline up to 240 minutes after injection	Standardized Uptake Value (SUV) will be the primary unit for assessment. Using standard PET/CT viewing software, the SUV will be measured for different organs and lesions of suspected disease and compared to reference/background tissues.

Trial Locations

Locations (1)

UCLA / Jonsson Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States